MedTrace Logo

Utility and Acceptability of a Molecular Test in the Management of Sexually Transmitted Diseases in Uganda

NCT05994495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-04-29

No results posted yet for this study

Summary

The goal of this clinical trial is to assess utility and acceptability of a molecular test in comparison with clinical syndromic approach in the management of sexually transmitted diseases (STD) at STD clinic of Mulago National Referral Hospital in Uganda.

The main questions it aims to answer are:

* Does new molecular test improve appropriateness of therapy compared with the clinical syndromic approach without or with limited laboratory tests in the management of STDs?
* Are new molecular tests both clinically useful and acceptable in a Low-Middle Income Country for the management of STDs?

Participants will be put into two groups ("A" or "B"):

* Participants in group "A" will have a pus swab collected from urethra or vagina or a urine sample. After the result of the test, patients will be prescribed a specific drug.
* Participants in group "B" will have a pus swab collected from urethra or vagina or a urine sample, but participants in group "B" and their doctor will not know the results of the test. So, participants in group "B" will be given treatment in the standard way, according to the current clinical practice.

Conditions

  • Sexually Transmitted Diseases

Interventions

DIAGNOSTIC_TEST

nuclear acid amplification tests

The NAAT test will be performed with Bosch Vivalytic STI test. It is a qualitative Polymerase Chain Reaction-based assay for simultaneous detection of 10 common sexually transmitted pathogens: Herpes simplex virus 1 (HSV 1)- Herpes simplex virus 2 (HSV 2)- Chlamydia trachomatis (CT) - Haemophilus ducreyi (HD)- Mycoplasma genitalium (MG) - Mycoplasma hominis (MH) - Neisseria gonorrhoeae (NG) - Treponema pallidum (TP)- Ureaplasma urealyticum (UU) - Trichomonas vaginalis (TV)

OTHER

Clinical Syndromic Approach

Physical examination

Sponsors & Collaborators

  • Societa' Italiana Di Malattie Infettive E Tropicali

    collaborator OTHER

  • Riccardo Serraino

    lead OTHER

Principal Investigators

  • Carlo Torti · Magna Graecia University of Catanzaro, Italy

  • Patrick Musinguzi · Mulago National Referral Hospital, Kampala, Uganda

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-01-30
Completion
2025-03-30

Countries

  • Uganda

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05994495 on ClinicalTrials.gov